Harmonised standards have the meaning that they can be used by manufacturers for proof of conformity wit EU legislations such as PED..
A harmonised standard is a European standard elaborated on the basis of a request from the European Commission to a recognized European Standards Organisation (CEN, CENELEC or ETSI) to develop a European standard that provides solutions for compliance with a legal provision. European standards, including harmonised standards, may be based fully or partially on international ISO or IEC standards.
Start and presumption of conformity for harmonised standards
It is important to note that the definition of a harmonised standard does not contain any reference to the publication of its reference in the EU official journal. As long as a reference of a harmonised standard is not published in the EU official journal, the harmonised standard, or parts thereof, does not give presumption of conformity with the essential or other requirements it aims to cover. The publication in EU official journal also specifies the date from which the presumption of conformity begins and when a presumption of conformity expires (for withdrawn or updated standards).
Harmonised standards replace legally binding essential requirements. A technical specification given in a harmonised standard is not an alternative to a relevant essential or other legal requirement but only a possible technical means to comply with it.
In risk related harmonisation legislation this means in particular that manufacturers always, even when using harmonised standards the references of which are published in the EU Official Journal, remain fully responsible for assessing all the risks of their product in order to determine which essential (or other) requirements are relevant.
When applying a harmonised standard, it can be assumed that the corresponding requirements listed in Annex ZA are fulfilled with the legal provisions mentioned there (presumption of conformity).
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What are harmonised standards in accordance to EU legislation?
